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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  02/21/2008
 
Trade Name:  Humira
 
Generic Name or Proper Name (*):  adalimumab
 
Indications Studied:  Treatment of juvenile idiopathic arthritis
 
Label Changes Summary:  * Indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA)in patients 4 years of age and older * Has not been studied in children <4 years of age; there are limited data on treatment in children with weight <15 kg * Safety and efficacy in pediatric patients for uses other than JIA have not been established * Adalimumab was studied in 171 patients 4 - 17 years with polyarticular JIA. * AEs were generally similar to those seen in adults. 45% of children experienced an infection while receiving adalimumab with or without concomitant MTX in the first 16 weeks of treatment. Serious infections were observed in 4% of patients within approximately 2 years of initiation of treatment * Information on dose, AEs, lab abnormalities, PK parameters, immunogenicity, immunization needs and clinical study * New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Abbott
 
NNPS:  FALSE
 
Therapeutic Category:  Anti-inflammatory
 
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